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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05967208
Other study ID # Pro00120208
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2025
Est. completion date April 1, 2027

Study information

Verified date July 2023
Source University of South Carolina
Contact Jan Ostermann, PhD
Phone +1-803-777-8747
Email jano@mailbox.sc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Despite worldwide efforts to promote HIV testing, rates of testing remain low. The purpose of this study is to evaluate the acceptability, efficacy, and cost-effectiveness of confidential SMS-based social network referrals for HIV testing as a means of reaching high-risk individuals and prompting them to test for HIV. To accomplish this purpose, the study has 5 specific aims: Aim 1 will conduct qualitative, formative work to identify desirable provider- and client-side characteristics of a confidential SMS-based HIV testing referral system. Aim 2 will adapt an existing mHealth system (mParis) to add CONSORT functionality. Aim 3 will pilot-test the CONSORT system to collect preliminary data on the system's acceptability, performance, and potential efficacy. Aim 4 will evaluate the acceptability and efficacy of CONSORT in a randomized controlled trial. Aim 5 will evaluate the incremental cost-effectiveness of CONSORT vs. other referral options. If CONSORT is shown to be acceptable, effective, and cost-effective, such mobile-phone supported, chain-referral methods could greatly improve the cost-effectiveness of HIV testing efforts.


Description:

No additional detail available


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date April 1, 2027
Est. primary completion date October 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - at least 18 years old - live, work, or regularly receive care in Moshi, Tanzania - literate Exclusion criteria: - under age 18 years - does not live, work, or regularly receive care in Moshi, Tanzania - illiterate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CONSORT referrals
Participants will be offered SMS-based confidential social network referrals for HIV testing ("CONSORT referrals") to extend to any of their social and sexual network contacts.
Card referrals
Participants will be offered physical invitation cards ("card referrals") to extend to any of their social and sexual network contacts.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of South Carolina Duke University, Kilimanjaro Christian Medical Centre, Tanzania

References & Publications (1)

Ostermann J, Njau B, Masaki M, Mtuy T, Itemba D, Hobbie A, Yelverton V, Moore S, Yamanis T, Thielman NM. Feasibility, Acceptability, and Potential Cost-Effectiveness of a Novel Mobile Phone Intervention to Promote Human Immunodeficiency Virus Testing Within Social Networks in Tanzania. Sex Transm Dis. 2022 Nov 1;49(11):778-781. doi: 10.1097/OLQ.0000000000001611. Epub 2022 Jan 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Uptake of HIV testing The number of referred clients presenting for HIV testing at participating study sites within 30 days of the testing offer, per 100 index clients. Within 30 days of the time of the testing offer
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